Lymphedema Letter of Medical Necessity

Because lymphedema is not well understood, it may be necessary to file a Letter of Medical Necessity for either a proposed treatment or in conjunction with appealing an insurance company denial of coverage.

This section will provide information as to what these letters should contain and will provide links for further assistance.

WHAT SHOULD BE IN A LETTER OF MEDICAL NECESSITY?

Policy Information Pipeline

Private Insurance

A skillfully drafted letter of medical necessity is an essential part of a request for funding for assistive technology. A letter of medical necessity, whether being submitted to the Department of Human Services, a private insurance company or other funding source, should contain the information needed to convince the reader that the requested assistive technology is necessary to meet the medical needs of the person for whom the assistive technology is being requested. This fact sheet is intended as a guide to preparing such a letter of medical necessity.

The letter of medical necessity should be written by a medical professional familiar with the requesting party's medical condition. The professional should briefly describe their credentials and relationship to the requesting party. This professional may be a physician, a nurse, a physical therapist, an occupational therapist or other medical professional. However, note that most funding sources require a physician's prescription as part of the funding request. Therefore, letters of medical necessity not written by a physician should be endorsed by a physician or accompanied by a physician's prescription.

ELEMENTS OF A LETTER OF MEDICAL NECESSITY

1. Disability Description - The letter should contain, usually at the beginning, a thorough description of the requesting party's disability. This description should include an explanation of how the disability affects the requesting party's function. For example, the affects of the disability on the use and function of the requesting party's legs. The disabling condition(s) and/or functional limitation(s) which necessitate the request for the assistive technology should be highlighted.

2. Assistive Technology Description - The assistive technology being requested should be described in some detail. A more thorough description is required when the requested technology is new, unique, customized or not frequently requested.

3. Assistive Technology Relationship to Medical Needs - The letter should explain how the requested assistive technology addresses the requesting party's medical needs or functional limitations. Generally in this context, a medical need is not a need to receive medical treatment. Rather, it is a need to compensate for a function which is limited as a result of a disability. For example, a requesting party has a medical need for a wheelchair to compensate for lost function in the lower extremities and to have a functional means of mobility.

4. Inability of Alternatives to Meet Medical Needs - Where there are alternatives, especially less expensive alternatives, available to meet the requesting party's medical needs, the letter should explain why these alternatives are not appropriate for the
requesting party. Also, the specific features which make the requested technology the necessary and appropriate alternative should be identified,

5. Ability to Use Technology - The letter should detail the requesting party's ability to use the requested assistive technology. This is especially important when the technology is motorized, electronic or particularly sophisticated. For example, when a power wheelchair is being requested, the requesting party's ability to safely operate a power wheelchair should be noted. If there was a trial with the requested device the results of this trial should be summarized.

6. Requested Assistive Technology as Community Standard- The letter should justify and explain the requesting party's need for the assistive technology. This justification should be in terms of the community standard of practice by the medical professional's peer group. The medical professional should explain that it is the standard practice or current practice in their medical profession to provide the requested assistive technology to persons with the requesting party's disability.

The letter that follows is a sample letter of medical necessity. The numbers contained in the letter correspond to the numbered elements of a letter of medical necessity.

This fact sheet was produced with funds from the Governor's Advisory Council on Technology for People with Disabilities/STAR Program funded by the National Institute on Disability and Rehabilitation Research under the Technology-Related Assistance for Individuals with Disabilities Act of 1988 as amended, P.L. 103-018. This fact sheet may be reproduced; if reproduced in its entirety, with credit to the Minnesota Disability Law Center.

1Ms. Jane Doe is a 30-year-old woman with C5-6 quadriplegia related to a motor vehicle accident in 1985. Despite her significant disabilities, she had been ble to achieve independent living with the assistance of a personal care attendant. 1However, she continues to have difficulties with environmental controls within her home due to her impaired upper extremity function.

1Due to Ms. Doe's high level of injury, she is unable to use her upper extremities to control her environment. She is in need of being provided with appropriate technology for permanent use. I recommend that a voice recognition system from Advanced Speech Interface Systems, Inc., be purchased and installed in Ms. Doe's present residence. 2This company has demonstrated their equipment to us and will be able to provide ongoing service of their product.

6This system is medically necessary and is accepted among the medical community because it provides persons with C5-6 quadriplegia (like Ms. Doe) independent living to generate self-care and self-esteem as mandated under federal law. 6In order to maximize Ms. Doe's functional independence, an environmental control system is medically necessary. 3She would benefit from a 2voice-controlled system that allows her the ability to control many functions within her home such as opening doors to exit her residence in emergency situations such as a fire 4since she is currently unable to do this without the assistance of a personal care attendant. 2This system will also allow her to change the room temperature to prevent hypothermia 3since a person with C5-6 quadriplegia has difficulty maintaining a normal body temperature. 2In addition, it will provide her with the means to dial a phone by using voice commands in the event of an emergency. 3Because of her condition, this system will increase her functional capabilities and decrease her need and use for a personal care attendant.

Ms. Doe needs this system immediately. She is not going to recover nor regain any of her functional ability due to her disabling condition which occurred nine years ago. I recommend that this system be provided by Advanced Speech Interface Systems, Inc. 2This company has been in this field of expertise for ten years. They are a recognized medical assistance provider, and they are supported by the medical community. The system provided by Advanced Speech Interface Systems, Inc., will be customized to Ms. Doe's medical needs. 6Because this system will -be specifically catered towards her health needs, it represents an effective and appropriate use of program funds.

Ms. Doe has been diagnosed with a chronic disease for which there is no cure. Effective treatment and disease management is available that will assist her in managing her disease independently, and in preventing exacerbation and expensive associated health complications. The treatment I have ordered is essential for providing treatment and long-term disease management for your member, Jane Doe.

I have ordered manual lymph drainage, which is a massage technique that assists the body redirecting lymph drainage, and in opening new pathways for lymph to flow. This therapy is a physical therapy technique and must be applied by a certified lymphedema therapist. Ms. Doe will require six to eight weeks of therapy with applications of compression bandaging in order to achieve significant results. She will also require education on self-application for continued long term disease management. Manual Lymph Drainage with effective external compression are required and have been documented in clinical studies to achieve significant reduction of edema, and in long-term disease management. (Cancer 2002: 95:2260-2267)

In order to achieve significant edema reduction and effective long-term disease management, I have ordered a twelve-chambered LymphaPress gradient sequential pump to be applied at 60 mmHg for 2 hours BID, with inclusion of the Reid Optiflow Foam Compression Inserts with pump therapy and for nighttime compression. Manual Lymph Drainage and good external compression devices have proven very effective in the treatment and management of chronic lymphedema, and have proven to provide patients with optimal results long-term. (Cancer 2002; 95:2260-2267)

The LymphaPress twelve-chambered gradient pump is a device that applies gradient sequential compression using a thirty-second cycle. This device has proven to significantly reduce edema, prevent and promote chronic wound healing, and prevent infection as it pushes the edema causing fluid back into the vascular system for elimination from the body. This device also promotes venous return and allows the delivery of blood flow to the skin to keep it healthy. The LymphaPress is required in order to ensure patient compliance, and better achieve and maintain significant edema reduction. The LymphaPress contains twelve chambers, operates on a thirty-second cycle, and in doing so, decreases pain upon compression. The increased number of chambers also reduces the incidence of over-compressing superficial lymphatics, which can result in exacerbation of condition rather than reduction. A non-gradient pump would be harmful for this patient, as these devices, in applying uniform compression have shown to exacerbate edema, and significantly increase pain upon compression, as uniform compression causes a backflow and trapping of fluid in the distal veins. (Surgery 1990;108:871-875)

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July 1, 2004

Jane Doe

The Reid Optiflow Custom Foam Compression Binders apply gradient pressure, assist in directing fluid to working lymphatics while protecting the superficial lympahtics. This device assists in the breakdown of fibrotic tissue that would not otherwise allow for complete elimination of excess edema causing fluid. This device is very effective in reducing pain associated with external mechanical compression therapy, increasing compliance, and increasing reduction treatment time.

I believe any treatment other than what I ordered, will only delay good results, or even cause exacerbation. If Ms. Doe does not obtain the items and treatment needed to effectively treat and manage her disease long term, her condition will exacerbate, and she will experience complications that are very expensive to treat. Health complications that commonly occur with untreated or ineffectively treated lymphedema are cellulitis, non-healing wounds, deformation of limbs, debilitating edema, decreased quality of life, and in worse cases, amputation. Ms. Doe will need the LymphaPress twelve-chambered Gradient pump with Optiflow Inserts for long-term home disease management for the remainder of her lifetime, as her disease is chronic. I believe that if Ms. Doe obtains the Manual Lymph Drainage, LymphaPress with Optiflow, she will be more successful with long-term disease management.

All treatment ordered is evidence based as supported by URAC, for effective long-term disease management of lymphedema. I believe that failure to approve coverage for treatment exactly as written in a timely manner will compromise my patient’s health, and would constitute cause for a malpractice complaint to the State’s Medical Board.

Should you choose to deny treatment exactly as ordered, please submit the following information to the insured and to my office with your denial:

1. Credentials specific to lymphatic and vascular disease of the person denying coverage for treatment.

2. Clinical studies used to make the decision to deny coverage for treatment for my patient.

3. Date and time the person making the decision to deny coverage for treatment physically examined my patient.

4. Letter describing how the decision to deny coverage is in the best interest of patient care.

5. Letter guaranteeing the decision to deny coverage will not cause physical harm to my patient.

Thank you for your prompt attention to this matter. If you have any questions, please feel free to contact me at (702)222-2222.

Sincerely,

John Doctor

Sample Letter 3. of Medical Necessity

Sample

Date

Contact Name
Re:
Patient Name

Insurance Company

Policy Number

Address

Group Number

City, State Zip

Diagnosis

Dear [Medical Director’s Name]:

On behalf of my patient, [patient name], the purpose of this letter is to provide written documentation of medical necessity for Zevalin™ (Ibritumomab tiuxetan), which I have prescribed for the treatment of [diagnosis and diagnosis code]. In support of the medical necessity of the Zevalin regimen, I have included the patient’s treatment history and a description of Zevalin.

Patient History and Diagnosis

[Patient name] is a [age]-year-old [male/female] who has been under treatment for [diagnosis] since [date]. During this time, [patient] has been treated with other therapies including [discuss previous therapies and patient’s response to therapy]. [Continue with patient history and clinical support for medical necessity.]

Treatment Information

Zevalin, as part of the Zevalin therapeutic regimen, is FDA-approved and is indicated for the treatment of patients with relapsed or refractory low-grade, follicular or transformed B-cell non-Hodgkin's lymphoma, including patients with Rituximab refractory follicular non-Hodgkin's lymphoma. Zevalin is a two-step regimen that includes administration of Zevalin, a murine anti-CD20 monoclonal antibody, linked to the radioisotope indium-111 for imaging to assess biodistribution, and a separate administration seven to nine days later of Zevalin linked to the radioisotope yttrium-90, which can damage or destroy cancer cells. In a multicenter study of patients (n=54) with relapsed follicular NHL refractory to Rituximab, the Zevalin regimen produced an overall response rate of 74%. Patients were considered refractory if their last prior treatment with Rituximab did not result in a complete or partial response or if time to disease progression was less than 6 months. In a randomized multicenter trial of the Zevalin regimen versus Rituximab in patients with relapsed or refractory low-grade, follicular or transformed B-cell NHL, the Zevalin regimen produced an overall response rate of 80% (n=73) versus 56% with Rituximab (n=70). Responses were determined by an independent panel using International Workshop response criteria.

In the spirit of immediate patient access to Zevalin, a potentially life-saving therapy for [diagnosis], please consider this letter as sufficient documentation to justify the medical necessity of the Zevalin regimen for my patient, [patient name]. Please call me at [physician phone number] if you have any questions or require additional information regarding this patient’s treatment.

PATIENT ADVOCACY LINKS

National Insurance Consumer Helpline

A general information source for all types of insurance-related issues, including life and health insurance

800-942-4242

Patient Advocacy Coalition

303-744-7667

The Coalition focuses on assisting people in the appeals process when an insurance company has denied coverage for medical treatments. They provide free advice and support on how to present a comprehensive and compelling case

Patient Advocate Foundation (PAF)

800-532-5274

help@patientadvocate.org

This organization serves as an active liaison between the patient and their insurer, employer and/or creditors to resolve insurance, job discrimination and/or debt crisis matters relative to their diagnosis

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